PeriodontitisPhase 4FSNCT01538927
Effect of Fibrin Sealant on Early Wound Healing
A Phase 4 study testing Fibrin Sealant and Suture in people with Periodontitis, run by Chhattisgarh Dental College and Research Institute at 1 site in India.
Trial summary
The aim of this randomized controlled clinical trial is to compare wound healing after the use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for their periodontal (gum)problems are selected and invited. Two regions will be operated in a selected patient. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Fibrin Sealant and Suture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2012to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A subject has to be between the ages of 18 and 60 years.
- Severe Periodontitis: Presence of a jaw with each quadrant having atleast 4 teeth with a probing depth of ≥ 6mm and is indicated for periodontal flap surgery.
- Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.
- Good oral hygiene: Full-mouth plaque score (FMPS) < 25%.
- Low levels of residual infection: Full-mouth bleeding score (FMBS) < 25%.
- Endodontic status: Teeth had to be vital or properly treated with root canal therapy
Who cannot join
- History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
- Current or former smokers.
- Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.
- Mobility of selected teeth.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
India1 site
Chhattisgarh Dental College and Research Institute
Rāj-Nāndgaon, Chhattisgarh, 491441
About this study
Official title: Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial.
The aim of this randomized controlled clinical trial is to compare wound healing after the use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for their periodontal (gum)problems are selected and invited. Two regions will be operated in a selected patient. One region will receive fibrin sealant (test site) and the other region will get sutures (control site). Wound healing will be assessed by evaluating inflammatory markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid.
Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels of interleukin (1beta and 8) compared to use of sutures.
- Conditions
- Periodontitis
- Being tested
- Fibrin Sealant, Suture
- Keywords
- fibrin sealant, tissue adhesive, wound healing, interleukin 1 beta, interleukin 8
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin SealantDrug
Also called TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treated
Fibrin Sealant 4ml (Baxter Tisseel)
SutureDrug
Also called Ethicon
Black silk 000
| Study group | Role | What they receive |
|---|---|---|
| Fibrin Sealant | Experimental | One quadrant surgically elevated will be closed with fibrin sealant Receives: Drug: Fibrin Sealant |
| Suture | Placebo comparator | The surgically elevated flap is closed with non resorbable sutures. Receives: Drug: Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of cytokines.
Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.
Measured: 7 days
Secondary outcomes (1)
Clinical inflammation
Gingival inflammation will be assessed at a clinical level.
Measured: 7, 14 and 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chhattisgarh Dental College and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Dr Shaju Jacob P, Chhattisgarh Dental College and Research Institute
- Investigators
- Shaju P Jacob, MDS, Principal investigator, Chhattisgarh Dental College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01538927
- Sponsor's protocol ID
- CDC0212-FS
- Other IDs
- CTRI/2012/05/002628
- Acronym
- FS
- Status last verified
- Dec 2012
- First submitted
- 10 Feb 2012
- Last updated
- 25 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Early Wound Healing Following Use of Fibrin Sealant (FS) in Periodontal Surgery. A Controlled Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01538927
- Acronym / sponsor ID
- FS / CDC0212-FS
- Conditions
- Periodontitis
- Keywords
- fibrin sealant, tissue adhesive, wound healing, interleukin 1 beta, interleukin 8
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Chhattisgarh Dental College and Research InstituteUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Apr 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 24 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this randomized controlled clinical trial is to compare wound healing after the use of fibrin sealant and sutures for gum surgeries. 15 patients requiring gum surgery for their periodontal (gum)problems are selected and invited. Two regions will be operated in a selected patient. One region will receive fibrin sealant (test site) and the other region will get sutures (control site). Wound healing will be assessed by evaluating inflammatory markers, Interleukin 1beta and interleukin 8, from a non invasively collected gum fluid.
Hypothesis. Fibrin sealant use will result in less inflammation seen through reduced levels of interleukin (1beta and 8) compared to use of sutures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibrin Sealant | Experimental | Drug: Fibrin SealantOne quadrant surgically elevated will be closed with fibrin sealant |
| Suture | Placebo comparator | Drug: SutureThe surgically elevated flap is closed with non resorbable sutures. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- A subject has to be between the ages of 18 and 60 years.
- Severe Periodontitis: Presence of a jaw with each quadrant having atleast 4 teeth with a probing depth of ≥ 6mm and is indicated for periodontal flap surgery.
- Compliance: Only patients with optimal compliance, as assessed during the cause-related phase of therapy, are selected.
- Good oral hygiene: Full-mouth plaque score (FMPS) < 25%.
- Low levels of residual infection: Full-mouth bleeding score (FMBS) < 25%.
Key exclusion criteria (5 listed)
- History of any systemic disease such as diabetes mellitus, osteoporosis, unstable or life-threatening conditions, bleeding disorder, undergoing antibiotic or other antimicrobial therapy.
- Current or former smokers.
- Had undergone periodontal therapy in the past 6 months, or exhibit poor plaque control after phase I therapy.
- Mobility of selected teeth.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin SealantAlso: TISSEEL™ Kit, Two component Fibrin Sealant, Steam - treatedFibrin Sealant 4ml (Baxter Tisseel) | Drug | Fibrin Sealant |
| SutureAlso: EthiconBlack silk 000 | Drug | Suture |
Primary outcome
Concentration of cytokines.
Time frame: 7 days
Assess the concentration of Interleukin 1beta and Interleukin 8 in GCF of test and control sites after 7 days.
1 secondary outcome
Clinical inflammation
Time frame: 7, 14 and 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaju P Jacob, MDS principal investigator
Chhattisgarh Dental College and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fibrin Sealant and Suture in people with Periodontitis, run by Chhattisgarh Dental College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of cytokines. (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2012.